Date: 2017-04-25

Type of information: Acceptation for review of a NDA

Product name: Contrave© (naltrexone HCl and bupropion HCl)

Compound: naltrexone HCl and bupropion HCl

Therapeutic area: Metabolic diseases

Action mechanism: Contrave® is a combination of naltrexone and bupropion, in an extended-release formulation. Naltrexone is approved to treat alcohol and opioid dependence. Bupropion is approved to treat depression and seasonal affective disorder and as an aid to smoking cessation treatment.

Company: Valeant Pharmaceuticals (Canada) Orexigen Therapeutics (USA - CA)

Disease: chronic weight management in adults

Latest news: • On April 25, 2017, Orexigen Therapeutics announced that Health Canada has completed its screening phase and accepted for review a New Drug Submission for marketing approval of Contrave® (naltrexone HCl and bupropion HCl). The regulatory submission was filed by Valeant Canada. If approved, Valeant will market and distribute Contrave® in Canada as part of its distributorship agreement with Orexigen, executed in August 2016. Under the terms of the agreement, Valeant is responsible for obtaining regulatory approval and for all commercialization activity and expenses. Valeant expects to begin marketing Contrave® in the first half of 2018, if regulatory approval is obtained. According to data from Statistics Canada, obesity and related comorbidities continue to be a growing problem in Canada, with almost two thirds of Canadian adults either overweight or struggling with obesity. Estimates of the economic burden of obesity in Canada range from $4.6 billion to $7.1 billion annually.1 Orexigen has partnerships to commercialize Contrave® and Mysimba® (naltrexone HCl / bupropion HCl prolonged release) in a total of 39 countries worldwide, including partnerships with Valeant in Canada, Australia, New Zealand, South Africa and 21 European countries.


Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization: 2014-09-10

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes